Rise and shine, everyone, another busy day is on the way. Already, the Pharmalot campus has been bustling as the official mascots have been busy chasing assorted creatures in search of their breakfast. As for us, yes, we are firing up the trusty kettle once again and brewing another cuppa stimulation. Our choice today is Earl Gray. Now, though, the time has come to get still busier. On that note, here are some tidbits. Have a lovely day and do keep in touch. …
As links between pharmaceutical companies and telehealth providers grow, health policy experts and legislators are raising concerns over the large fees that telehealth companies can receive from drugmakers each year, STAT explains. Critics have questioned whether those partnerships break federal laws prohibiting financial kickbacks to induce prescribing, highlighting their potential to promote uncoordinated care and overprescriping of unnecessary, and often expensive, branded medications. The same questions apply to coupons extended for a drug-specific telehealth visit. Drugmakers have long used discount coupons to encourage patients to use their high-cost medications. But coupons can influence not just the out-of-pocket price for the drug, but the cost of consulting with a clinician who can prescribe it.
U.S. Health and Human Services Secretary Robert F. Kennedy Jr. told a Senate hearing on Wednesday that he had nothing to do with a U.S. Food and Drug Administration decision to not approve Replimune’s advanced skin cancer drug, saying it was in the hands of FDA Commissioner Marty Makary, Reuters writes. Earlier this month, the FDA declined to approve the drug after taking issue with the company’s reliance on a single‑arm study for the drug without a control group. In its letter, the FDA said the company must provide data from a well-controlled trial demonstrating adequate evidence of effectiveness. “This decision comes out of FDA, and we trust the process there. And I’ve been told by Marty Makary that every panel that looked at that drug unanimously voted against it … because it does not appear to work,” Kennedy said. An op-ed in The Wall Street Journal maintained Kennedy’s comments were not true and cited cancer doctors who have worked on trials of the drug and said it was effective.
